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The efficacy of cold-gel packing for relieving episiotomy pain – a quasirandomised control trial a
b
c
d
Yu-Ying Lu , Mei-Ling Su , Meei-Ling Gau , Kuan-Chia Lin & HengKien Au
e
a
Department of Nursing, National Taipei University of Nursing and Health Sciences, Taiwan b
Department of Nursing, Taipei Medical University Hospital, Taiwan c
Click for updates
Graduate Institute of Nurse-Midwifery, National Taipei University of Nursing and Health Sciences, Taiwan d
Director of Department of Health Care Management, National Taipei University of Nursing and Health Sciences, Taiwan e
Department of Obstetrics and Gynecology, Taipei Medical University Hospital, Taiwan Published online: 10 Jun 2015.
To cite this article: Yu-Ying Lu, Mei-Ling Su, Meei-Ling Gau, Kuan-Chia Lin & Heng-Kien Au (2015): The efficacy of cold-gel packing for relieving episiotomy pain – a quasi-randomised control trial, Contemporary Nurse, DOI: 10.1080/10376178.2015.1010257 To link to this article: http://dx.doi.org/10.1080/10376178.2015.1010257
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Contemporary Nurse, 2015 http://dx.doi.org/10.1080/10376178.2015.1010257
The efficacy of cold-gel packing for relieving episiotomy pain – a quasirandomised control trial Yu-Ying Lua*, Mei-Ling Sub, Meei-Ling Gauc, Kuan-Chia Lind and Heng-Kien Aue
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a
Department of Nursing, National Taipei University of Nursing and Health Sciences, Taiwan; bDepartment of Nursing, Taipei Medical University Hospital, Taiwan; cGraduate Institute of Nurse-Midwifery, National Taipei University of Nursing and Health Sciences, Taiwan; dDirector of Department of Health Care Management, National Taipei University of Nursing and Health Sciences, Taiwan; eDepartment of Obstetrics and Gynecology, Taipei Medical University Hospital, Taiwan (Received 1 February 2014; accepted 31 December 2014) Purposes: This study evaluated the effectiveness of cold-gel packing on episiotomy pain among postpartum women who had normal spontaneous deliveries. Methods: A quasi-randomised control trial was conducted in a maternity ward of a regional teaching hospital in northern Taiwan. Seventy postpartum women were recruited, choosing to be in either the experimental or control group (35 women per group). Subjects in the experimental group received at least six interventions of cold-gel packing applied to the perineal wound and were provided oral analgesics routinely. The subjects in the control group received oral analgesics routinely. Findings: Pain intensity, pain interference on daily activities and satisfaction levels with pain management were assessed using Brief Pain Inventory (BPI) and pain management questionnaire, respectively. The results showed that women in the experimental group reported significantly lower mean pain intensity score, pain interference on daily activities scores at 48 hours post-delivery, and higher level of satisfaction with pain management at 24 and 48 hours post-delivery than the control group after adjusting for demographic and obstetric data. Conclusions: Cold-gel packing on the perineum is a cost-effective, convenient, easy-to-deploy and non-pharmacologic approach to pain reduction, with an overall positive impact on postpartum recovery for parturients. Keywords: cold-gel packing; episiotomy; postpartum women
Introduction Historically, episiotomy has been routinely performed by obstetricians and midwives, with the rationale of preventing extensive perineal tearing and increasing the vaginal outlet diameter to facilitate a baby’s birth (Karaçam, Ekmen, Çalışır, & Şeker, 2013; Macleod et al., 2013). In a number of systematic reviews, it has been reported that routine episiotomy may achieve more harm than benefits, such as contributing to third- and fourth-degree tears, unsatisfactory anatomic results, increased blood loss, increased postpartum pain, higher rates of infection and dehiscence, sexual dysfunction and possible increased risk of perineal lacerations in subsequent deliveries (Carroli & Mignini, 2009; Steiner, Weintraub, Wiznitzer, Sergienko, & Sheiner, 2012). Thus,
*Corresponding author. Email: [email protected] © 2015 Taylor & Francis
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the World Health Organization recommends that episiotomy be performed only for a strictly limited number of indications, at a rate of around 10% (Liljestrand, 2003; WHO, 1996). In Taiwanese society, the fear of severe perineal injury and potential associated long-term morbidities among physicians has contributed to the high incidence of episiotomy (Lai, Cheung, Lao, Lau, & Leung, 2009). Thus, episiotomy has been utilised in more than 90% of births (Graham, Carroli, Davies, & Medves, 2005; Kuo, 2005; Shahraki, Aram, Pourkabirian, Khodaee, & Choupannejad, 2011). Whilst there is support for an evidence-based approach to performing episiotomies in Taiwan, one immediate concern is to develop the intervention for relieving discomfort after episiotomy for Taiwanese women. Perineal pain is a common experience for postpartum women exposed to episiotomy (Santos et al., 2012; Shahraki et al., 2011). Perineal pain not only interferes with these women’s physical recovery, such as in urination and bowel movement discomfort, but it also affects early maternalnewborn attachment and subsequent newborncare (Andrews, Thakar, Sultan, & Jones, 2008; Hedayati, Parsons, & Crowther, 2003; Macleod et al., 2013; Steen & Marchant, 2007). Moreover, perineal pain is generally underestimated by postpartum women, her family and health professionals. During this period, women generally suffer silently from a preventable pain because attention to the newborn takes precedence for them (Navvabi, Kerman-Saravi, Saroneh, & Abedian, 2011). In fact, perineal pain has been reported most severe on the first day post-delivery, peaking at 24 hours postpartum, and then gradually diminishing by 48 hours postpartum (Macarthur & Macarthur, 2004; Steen, 2005). Perineal pain may continue for a few days or even several months (Declercq, Cunningham, Johnson, & Sakala, 2008; Steen, 2008). A number of factors may influence the severity of perineal pain such as parity, type of delivery, birth experiences, degree of perineal trauma and neonatal birth weight. Macarthur and Macarthur (2004) indicated that perineal pain was more common among primiparous than multiparous women. Leeman et al. (2009) reported that the more weight that a woman gains during pregnancy, the longer her second stage of labour. Consequently, her perineal trauma is more severe and analgesic use is more frequent. Both pharmacological and non-pharmacological methods have been employed to treat perineal pain and discomfort. In Taiwan, most postpartum women take NSAIDs routinely after childbirth for pain control. Oral medications, however, may have side-effects, such as ulcer formation, nausea, vomiting and renal dysfunction (Musa, Palwai, & Eriksson, 2011; Tsai & Tsai, 2010). Moreover, prescribing analgesics during lactation is a controversial convention, adverse drug reactions in neonates and infants may result. Non-pharmacological methods commonly include the use of hot and cold compresses and vaginal washes. Among these treatments, localised cold-gel packing has emergered as an easily-handled, low-cost, non-invasive, with mininal side effects resource for reducing perineal pain, swelling and bruising post-vaginal delivery (East, Begg, Henshall, Marchant, & Wallace, 2012; Jahdi, Sheikhan, Merghati, & Haghani, 2010; Navvabi, Abedian, & Steen, 2009; Navvabi et al., 2011). Review studies have shown that cold treatment has clear efficacy in reducing pain without delaying wound healing. Navvabi et al. (2009) conducted a randonmised controlled trial, in which 121 healthy women were divided into three groups of control and cold therapy (using pads containing a cooling gel and ice pack). Between the three groups, results indicated a significant statistical difference in the sedation of pain, as well as an interference of pain with mood and daily activities (sitting, babysitting and social activities). Pads containing cooling gel acted better than ice packs in reducing the complications from episiotomy. In a single-blind clinical trial study from Jahdi et al. (2010), 60 primiparous women were randomly assigned to experimental and control groups. Participants in the experimental group received cold-gel pads (for 20 minutes four hours after labour and, in certain cases, for up to five days) while the control group received
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routine hospital care. The results indicated a significant difference in the reduction of pain intensity between the two groups at four hours, 12 hours, and five days post-episiotomy. In addition, analgesics usage within the cold-gel pad group was significantly lower than that within the control group. In a randomised controlled trial undertaken at one Iranian hospital (Navvabi et al., 2009), 121 primiparous women at term who had an episiotomy were randomly recruited into three groups (Group 1: no localised cooling; Group 2: ice pack cooling; Group 3: cooling gel). The results showed that localised cooling treatments were effective in alleviating perineal pain at four hours, two days, and 10 days post-episiotomy, particularly within the cooling gel pad group. Wound healing rates were also reported to be higher within the cooling gel pad group. This trial also revealed that women were more satisfied when applying cooling gel pads. Although many reports have studied the efficacy of localised cooling treatment in relieving perineal pain of various origins, in Taiwan cold-gel packing for relieving perineal pain is not routinely applied. Among Taiwanese postpartum women and their families, ‘doing the month’ or ‘sitting the month’ are well accepted and respected traditional practices/customs followed by almost all Chinese worldwide. Women who are ‘doing the month’ are advised to avoid eating or having contact with any cold food or cold materials, as these are considered potentially harmful to their recovery (Bao et al., 2010). Given the cultural practice of remaining warm for one month following birth, this study is therefore important for this Chinese cultural group in Taiwan. To date, no previous study has investigated the effects of cold-gel packing on post-episiotomy pain in Taiwan, even though pain relief is considered the first priority in postpartum care. The study objective was to evaluate the effectiveness of localised cold-gel packing as a pain relief resource employed in postpartum women who had experienced vaginal birth with an episiotomy. This study could provide a clinical practice based on scientific evidence. Methods We used a quasi-randomised control trial; participants chose to have either the experimental or control group. Participants and setting This clinical study was conducted in the maternity ward of a Taipei City teaching ward that averages 50–80 births monthly. The study period extended from January to May 2010. During the data collection period, the average monthly births were 67 and rate of caesarean section was 44%. Most vaginal deliveries (more than 90%) received episiotomy at this hospital. The inclusion criteria included: women aged ≥18 years, delivering their child between 37 and 42 gestational weeks, with their newborn weighing between 2500 and 4000 grams at delivery. The exclusion criteria included: women who had medical or psychological disorders, delivered twins or a higher order gestation, and had any postpartum complications during the postparturition period. Sample size calculations were based on the Navvabi et al.’s study (2009), which used a Numerical Rating Scale (0–10) of the intensity of perineal pain (0 = no pain to 10 = worst possible pain). Our primary outcome was women’s pain intensity (0–10), measured as part of the Brief Pain Inventory, described below, 48 hours after giving birth. In order to detect a clinically significant reduction in pain scores from 4.36 (mean score at Day 2 postpartum in the control group) to 2.97 (in the cold-gel pad group), it was necessary to recruit 68 women into two groups (5% level of significance with 80% power). In anticipating a possible attrition rate of 10%, a target sample size of 37 participants per group was set.
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Instruments A structured questionnaire collected participant demographic and obstetric information. The intensity of pain and women’s satisfaction levels with pain management were the main measured outcomes. The pain intensity was measured by the short-form Brief Pain Inventory-Chinese version (Ger, 2004) and women’s satisfaction levels with pain management were evaluated by the pain management questionnaires within four hours of episiotomy repair (baseline), and at 12, 24 and 48 hours thereafter. The short-form Brief Pain Inventory consists of two subscales (pain intensity for two-item and pain interference on daily activities for seven-item). Ger (2004) reported a Cronbach’s alpha for the Brief Pain Inventory as .81 on the pain intensity subscale and .89 on the pain interference subscale. This questionnaire has been evaluated using a numeric rating scale (0–10). Higher scores indicated more intense pain and a more serious degree of pain interference on daily activities (including mood, sitting, lying down, walking, sleeping, urination, defecation). Our study’s Cronbach’s α coefficient for each subscale dimension ranged between .80 and .90 (n = 70). The questionnaire for women’s satisfaction level with pain management was developed by the researcher, and included a four-item questionnaire (such as satisfaction with pain management provisions from health-care providers, satisfaction with pain management resources). Scoring followed a six-point Likert-scale format, with 6 indicating very unsatisfied and 1 indicating very satisfied. Allocation to intervention or control group Potential participants, and those who met the study criteria, were approached individually. The study purpose and procedures were explained in detail by the researcher prior to providing written consent. Participants were informed of their right to withdraw from the study at any time. Seventy-three primiparous and multiparous women who had vaginal delivery with episiotomy and consented to participate were recruited and chose either the control or experimental group they wanted to be in. All participants received routine postpartum nursing care (including administered oral NSAIDs and warm sitz baths 24 hours after delivery).
Control group Control group participants provided demographic data after receiving routine postpartum care, responded to the BPI and satisfaction questionnaire at 4, 12, 24 and 48 hours after delivery.
Intervention group Cold-gel packing was the therapeutic intervention. Cold-gel pads were made of propylene glycol (antifreeze) and a cellulose compound (similar to that used in standard sanitary napkins). The cold-gel pad’s dimensions were 28 × 10 centimetres and weighed 242 grams. All experimental participants received an explanation about the intervention and its requirements, including (1) maintaining a cold-gel pad temperature between 12 and 150C, (2) replacing the cold-gel pad after 10 minutes of use in order to maintain the appropriate cooling temperature, (3) conducting one session to last 15–20 minutes. After receiving routine postpartum care and providing their demographic information, the experimental group participants took their first 15–20-minute cold-gel packing session. The researcher helped administer the first 15–20-minute intervention, and demonstrated how to apply cold-gel pads on the perineum. After that, participants were encouraged to use cold-gel packing frequently during the first four hours post-delivery. During the next three days, participants used it three times per day and as desired.
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The experimental group participants responded to the BPI and satisfaction questionnaire during the same time frame as the control group participants.
Data management
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The SPSS (18.0) statistical package was used for data analyses. Descriptive data analysis identified the demographic and obstetrics characteristics of the participants. Chi-squared, independent t-tests, or ANOVA, evaluated differences in demographic and obstetric variables between groups. The generalised estimating equations (GEE) model controlled the effects of study covariates and analysed the independent effects of cold-gel packing. The GEE approach considered withinperson variability and accounted for correlated data resulting from repeated measurements across different time points and multiple observations of the same individual (Zeger & Liang, 1986). A p-value < .05 (two-tailed) was considered statistically significant.
Ethics Hospital Institutional Review Board and nursing and maternity departments granted approval for this study (Taipei Medical University Hospital, IRB-2010-07-990707).
Findings A total of 73 women met the inclusion criteria and were enrolled in the study. Three participants withdrew their consent because of too many visitors, breastfeeding and rooming-in interference, and postpartum fatigue. As a result, the study included 35 participants in the experimental group and 35 in the control group. Table 1 provides a description of the 70 participants relative to demographic and obstetrical characteristics. Most subjects were nulliparas (87.1%), between 22 and 45 years of age (M = 32.1, SD = 4.3 years). The groups displayed no statistical differences in terms of demographic or obstetric variables (p > .05). We found that cold-gel packing decreased pain intensity, pain interference on daily activities and improved satisfaction with pain management. The mean pain intensity scores of the experimental group was 2.97 (SD = 2.73) and 5.57 (SD = 3.88) of the control group at 48 hours post-delivery (t = 3.24, p < .01; Table 2). The results of GEE show that changes to mean pain intensity scores indicated no significant differences between the experimental and control groups (p > .05). However, time-dependent changes indicated that post-test pain intensity scores decreased an average of 1.69∼6.81 points compared with pre-test results, implying a declining trend (Table 3). The interaction effect (group difference and time) revealed that the experimental group achieved a significantly greater drop in pain intensity values compared to their control group peers in the 48 hours post-delivery (β = −3.69, p < .01). In terms of mean pain interference on daily activities scores, at 48 hours post-delivery, the mean pain interference on daily activities scores for the experimental group (M = 41.23; SD = 14.11) were significantly lower than the control group (M = 33.51; SD = 12.21; t = 3.32, p < .001; Table 2). The results of GEE show that the changes to mean pain interference on daily activities scores indicated no significant differences between the experimental and control groups (p > .05). Time-dependent changes indicate that post-test pain interference on daily activities scores decreased an average of 8.43∼26.33 points over pre-test results, implying a declining trend (Table 3). The interaction effect (group difference and time) revealed that the experimental
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Table 1.
Demographics and obs-gyn information between two groups.
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Variables Age (M ± SD) Religious Yes No Occupation Yes No Education Senior high school and below College University and above Parity Nulliparous Multiparous Total weight gain (Kg, M, SD) The first stage of labour time (hour) M ± SD The second stage of labour time (hour) (M ± SD) Epidural anaesthesia Yes No Perineal trauma 1° laceration 2° laceration 3° laceration Using labour instruments Yes No Newborn weight(g, M, SD) New born Apgar Score 1 min (M ± SD) 5 mins (M ± SD)
Overall n = 70 N%
Experimental group n = 35 N%
Control group n = 35 N%
32.07 ± 4.30
31.34 ± 4.19
32.80 ± 4.34
17 (24.3) 53 (75.7)
8 (22.9) 27 (77.1)
9 (25.7) 26 (74.3)
17 (24.3) 53 (75.7)
11 (31.4) 24 (68.6)
6 (17.1) 29 (82.9)
14 (20.0) 19 (27.1) 37 (52.9)
7 (20.0) 7 (20.0) 20 (60.0)
7 (20.0) 12 (34.3) 16 (45.7)
61 (87.1) 9 (12.9) 14.69 ± 4.51 4.40 ± 4.33
31 (88.6) 4 (11.4) 14.90 ± 3.51 4.49 ± 3.90
30 (84.7) 5 (14.3) 14.47 ± 5.38 4.30 ± 4.77
.69a .85a
0.92 ± 1.27
0.89 ± 1.26
0.94 ± 1.29
.87a
59 (84.3) 11 (15.7)
29 (82.9) 6 (17.1)
30 (85.7) 5 (14.3)
1 (1.4) 67 (95.7) 2 (2.8)
0 (0.0) 33 (94.3) 2 (5.7)
1 (2.9) 34 (97.1) 0 (0.0)
64 (91.4) 6 (8.6) 3082.94 ± 346.08
32 (45.7) 3 (4.3) 3080.17 ± 358.42
32 (45.7) 3 (4.3) 3085.71 ± 338.50
.95a
8.96 ± 0.43 9.93 ± 0.26
9.00 ± 0.54 9.91 ± 0.28
8.91 ± 0.28 9.94 ± 0.24
.41a .65a
p .06a .78b .27b .34b
.72c
.74b .22b
1.00c
Notes: a Independent samples t test; b Chi-Square; c Fisher exact test (When the expectations of cases less than 5).
group achieved a significantly greater drop in interference on daily activities values compared to their control group peers at 12, 24 and 48 hours post-delivery (β = −5.54∼14.49, p < .05). Participants in the experimental group reported higher levels of satisfaction with pain management than the control group at 24 hours and 48 hours post-delivery (p < .05; Table 2). The results of GEE show that the mean satisfaction with pain management scores indicate no significant differences between experimental and control groups (p > .05). Time-dependent changes indicated that post-test satisfaction with pain management scores decreased an average of 0.91∼1.46 points over pre-test results, implying a declining trend (Table 3). The interaction effect (group difference and time) revealed that the experimental group achieved a significantly greater drop in satisfaction with pain management scores compared to their control group peers at 12, 24 and 48 hours after delivery (β = −0.97∼ −1.20, p < .05).
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Table 2. Differences in pain intensity, pain interference on daily activities and satisfaction with pain management between the two groups (N = 70).
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Outcome variables Pain intensity pp 4 hours(before intervention) pp 12 hours pp 24 hours pp 48 hours Pain interference on daily activities pp 4 hours(before intervention) pp 12 hours pp 24 hours pp 48 hours Satisfaction with pain management pp 4 hours (before intervention) pp 12 hours pp 24 hours pp 48 hours
Experimental group M±SD
Control group M±SD
t
p
11.62 ± 4.06 10.00 ± 3.22 6.09 ± 3.12 2.97 ± 2.73
10.54 ± 3.62 8.80 ± 3.43 6.46 ± 0.356 5.57 ± 3.88
−1.18 −.1.51 0.48 3.24
.242 .136 .633 .002**
41.23 ± 14.11 30.03 ± 11.02 17.97 ± 10.53 7.66 ± 7.59
33.51 ± 12.21 27.86 ± 11.78 20.94 ± 10.88 14.43 ± 9.37
−2.45 −0.80 1.16 3.32
.017* .429 .250 .001***
7.60 ± 1.82 6.20 ± 1.53 6.06 ± 1.39 5.54 ± 1.09
7.31 ± 1.88 6.89 ± 1.41 6.74 ± 1.36 6.46 ± 1.40
−0.65 1.95 2.09 3.04
.520 .055 .041* .003**
Notes: PP = post-partum; *p < .05; **p < .01; ***p < .01
Discussion Perineal pain is often experienced by postpartum women with episiotomy. It may arise during the first hours after birth and persist for months (Declercq et al., 2008). A systematic review has demonstrated that localised cooling treatments were effective at reducing perineal pain, swelling and bruising without adversely affecting wound healing (Steen, Briggs, & King, 2006). Our research findings suggest that cold-gel packing is an effective strategy for relieving perineal pain at 48 hours post-delivery, consistent with the findings reported by Jahdi et al. (2010), whose research on cold-gel pad efficacy in reducing perineal pain found that used cold-gel packing during the postpartum period decreased pain intensity at four hours, 12 hours and five days post-episiotomy. Other authors discovered similar results, demonstrating the efficacy of its employment on perineal pain post-episiotomy (Navvabi et al., 2009, 2011). In addition, past studies have shown that perineal pain often interferes with maternal sleep, emotions, ambulation, defecation and urination, resulting in a poor quality of maternal sleep, emotional instability and prolonged postpartum recovery time. This study also demonstrated that cold-gel packing can effectively reduce perineal pain interference on daily activities at 12, 24 and 48 hours post-delivery. This finding confirms that of Navvabi et al. (2011), whose study found that ice treatments had an effect on the interference of perineum pain with mood, sitting, babysitting, social activities and urinating, on the tenth day post-delivery. This study also found that cold-gel packing could increase the satisfaction level with pain management reported by women who had undergone episiotomy. Our findings are similar to those reported by Navvabi et al. (2009). In this study, the majority of participants in the experimental group reported coldgel packing was effective at reducing perineal pain, swelling and discomfort. Cold-gel pads are very comfortable because of their soft texture and suitable temperature. Therefore, participants expressed high satisfaction with cold-gel packing and a willingness to cooperate. Limitations It was not possible to randomise women into experimental or control group because under Chinese cultural norms, women have the right to decide whether to apply cold temperatures
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Table 3. Generalised estimating equations model on the effect of outcome variables for cold-gel packing (N = 70).
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Item Pain intensity Group (Experimental vs. control) Time Baseline (4 hours) 12 hours 24 hours 48 hours Group × Time Group × Baseline Group × 12 hours Group × 24 hours Group × 48 hours Pain interference on daily activities Group (Experimental vs. control) Time Baseline (4 hours) 12 hours 24 hours 48 hours Group × Time Group × Baseline Group × 12 hours Group × 24 hours Group × 48 hours Satisfaction with pain management Group (Experimental vs. control) Time Baseline (4 hours) 12 hours 24 hours 48 hours Group × Time Group × Baseline Group × 12 hours Group × 24 hours Group × 48 hours
β
SE
−0.37
0.58
reference −1.69 −4.81 −6.81 reference
0.50 0.50 0.50
.001**
Contemporary Nurse Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/rcnj20
The efficacy of cold-gel packing for relieving episiotomy pain – a quasirandomised control trial a
b
c
d
Yu-Ying Lu , Mei-Ling Su , Meei-Ling Gau , Kuan-Chia Lin & HengKien Au
e
a
Department of Nursing, National Taipei University of Nursing and Health Sciences, Taiwan b
Department of Nursing, Taipei Medical University Hospital, Taiwan c
Click for updates
Graduate Institute of Nurse-Midwifery, National Taipei University of Nursing and Health Sciences, Taiwan d
Director of Department of Health Care Management, National Taipei University of Nursing and Health Sciences, Taiwan e
Department of Obstetrics and Gynecology, Taipei Medical University Hospital, Taiwan Published online: 10 Jun 2015.
To cite this article: Yu-Ying Lu, Mei-Ling Su, Meei-Ling Gau, Kuan-Chia Lin & Heng-Kien Au (2015): The efficacy of cold-gel packing for relieving episiotomy pain – a quasi-randomised control trial, Contemporary Nurse, DOI: 10.1080/10376178.2015.1010257 To link to this article: http://dx.doi.org/10.1080/10376178.2015.1010257
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content.
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This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http://www.tandfonline.com/page/termsand-conditions
Contemporary Nurse, 2015 http://dx.doi.org/10.1080/10376178.2015.1010257
The efficacy of cold-gel packing for relieving episiotomy pain – a quasirandomised control trial Yu-Ying Lua*, Mei-Ling Sub, Meei-Ling Gauc, Kuan-Chia Lind and Heng-Kien Aue
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a
Department of Nursing, National Taipei University of Nursing and Health Sciences, Taiwan; bDepartment of Nursing, Taipei Medical University Hospital, Taiwan; cGraduate Institute of Nurse-Midwifery, National Taipei University of Nursing and Health Sciences, Taiwan; dDirector of Department of Health Care Management, National Taipei University of Nursing and Health Sciences, Taiwan; eDepartment of Obstetrics and Gynecology, Taipei Medical University Hospital, Taiwan (Received 1 February 2014; accepted 31 December 2014) Purposes: This study evaluated the effectiveness of cold-gel packing on episiotomy pain among postpartum women who had normal spontaneous deliveries. Methods: A quasi-randomised control trial was conducted in a maternity ward of a regional teaching hospital in northern Taiwan. Seventy postpartum women were recruited, choosing to be in either the experimental or control group (35 women per group). Subjects in the experimental group received at least six interventions of cold-gel packing applied to the perineal wound and were provided oral analgesics routinely. The subjects in the control group received oral analgesics routinely. Findings: Pain intensity, pain interference on daily activities and satisfaction levels with pain management were assessed using Brief Pain Inventory (BPI) and pain management questionnaire, respectively. The results showed that women in the experimental group reported significantly lower mean pain intensity score, pain interference on daily activities scores at 48 hours post-delivery, and higher level of satisfaction with pain management at 24 and 48 hours post-delivery than the control group after adjusting for demographic and obstetric data. Conclusions: Cold-gel packing on the perineum is a cost-effective, convenient, easy-to-deploy and non-pharmacologic approach to pain reduction, with an overall positive impact on postpartum recovery for parturients. Keywords: cold-gel packing; episiotomy; postpartum women
Introduction Historically, episiotomy has been routinely performed by obstetricians and midwives, with the rationale of preventing extensive perineal tearing and increasing the vaginal outlet diameter to facilitate a baby’s birth (Karaçam, Ekmen, Çalışır, & Şeker, 2013; Macleod et al., 2013). In a number of systematic reviews, it has been reported that routine episiotomy may achieve more harm than benefits, such as contributing to third- and fourth-degree tears, unsatisfactory anatomic results, increased blood loss, increased postpartum pain, higher rates of infection and dehiscence, sexual dysfunction and possible increased risk of perineal lacerations in subsequent deliveries (Carroli & Mignini, 2009; Steiner, Weintraub, Wiznitzer, Sergienko, & Sheiner, 2012). Thus,
*Corresponding author. Email: [email protected] © 2015 Taylor & Francis
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the World Health Organization recommends that episiotomy be performed only for a strictly limited number of indications, at a rate of around 10% (Liljestrand, 2003; WHO, 1996). In Taiwanese society, the fear of severe perineal injury and potential associated long-term morbidities among physicians has contributed to the high incidence of episiotomy (Lai, Cheung, Lao, Lau, & Leung, 2009). Thus, episiotomy has been utilised in more than 90% of births (Graham, Carroli, Davies, & Medves, 2005; Kuo, 2005; Shahraki, Aram, Pourkabirian, Khodaee, & Choupannejad, 2011). Whilst there is support for an evidence-based approach to performing episiotomies in Taiwan, one immediate concern is to develop the intervention for relieving discomfort after episiotomy for Taiwanese women. Perineal pain is a common experience for postpartum women exposed to episiotomy (Santos et al., 2012; Shahraki et al., 2011). Perineal pain not only interferes with these women’s physical recovery, such as in urination and bowel movement discomfort, but it also affects early maternalnewborn attachment and subsequent newborncare (Andrews, Thakar, Sultan, & Jones, 2008; Hedayati, Parsons, & Crowther, 2003; Macleod et al., 2013; Steen & Marchant, 2007). Moreover, perineal pain is generally underestimated by postpartum women, her family and health professionals. During this period, women generally suffer silently from a preventable pain because attention to the newborn takes precedence for them (Navvabi, Kerman-Saravi, Saroneh, & Abedian, 2011). In fact, perineal pain has been reported most severe on the first day post-delivery, peaking at 24 hours postpartum, and then gradually diminishing by 48 hours postpartum (Macarthur & Macarthur, 2004; Steen, 2005). Perineal pain may continue for a few days or even several months (Declercq, Cunningham, Johnson, & Sakala, 2008; Steen, 2008). A number of factors may influence the severity of perineal pain such as parity, type of delivery, birth experiences, degree of perineal trauma and neonatal birth weight. Macarthur and Macarthur (2004) indicated that perineal pain was more common among primiparous than multiparous women. Leeman et al. (2009) reported that the more weight that a woman gains during pregnancy, the longer her second stage of labour. Consequently, her perineal trauma is more severe and analgesic use is more frequent. Both pharmacological and non-pharmacological methods have been employed to treat perineal pain and discomfort. In Taiwan, most postpartum women take NSAIDs routinely after childbirth for pain control. Oral medications, however, may have side-effects, such as ulcer formation, nausea, vomiting and renal dysfunction (Musa, Palwai, & Eriksson, 2011; Tsai & Tsai, 2010). Moreover, prescribing analgesics during lactation is a controversial convention, adverse drug reactions in neonates and infants may result. Non-pharmacological methods commonly include the use of hot and cold compresses and vaginal washes. Among these treatments, localised cold-gel packing has emergered as an easily-handled, low-cost, non-invasive, with mininal side effects resource for reducing perineal pain, swelling and bruising post-vaginal delivery (East, Begg, Henshall, Marchant, & Wallace, 2012; Jahdi, Sheikhan, Merghati, & Haghani, 2010; Navvabi, Abedian, & Steen, 2009; Navvabi et al., 2011). Review studies have shown that cold treatment has clear efficacy in reducing pain without delaying wound healing. Navvabi et al. (2009) conducted a randonmised controlled trial, in which 121 healthy women were divided into three groups of control and cold therapy (using pads containing a cooling gel and ice pack). Between the three groups, results indicated a significant statistical difference in the sedation of pain, as well as an interference of pain with mood and daily activities (sitting, babysitting and social activities). Pads containing cooling gel acted better than ice packs in reducing the complications from episiotomy. In a single-blind clinical trial study from Jahdi et al. (2010), 60 primiparous women were randomly assigned to experimental and control groups. Participants in the experimental group received cold-gel pads (for 20 minutes four hours after labour and, in certain cases, for up to five days) while the control group received
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routine hospital care. The results indicated a significant difference in the reduction of pain intensity between the two groups at four hours, 12 hours, and five days post-episiotomy. In addition, analgesics usage within the cold-gel pad group was significantly lower than that within the control group. In a randomised controlled trial undertaken at one Iranian hospital (Navvabi et al., 2009), 121 primiparous women at term who had an episiotomy were randomly recruited into three groups (Group 1: no localised cooling; Group 2: ice pack cooling; Group 3: cooling gel). The results showed that localised cooling treatments were effective in alleviating perineal pain at four hours, two days, and 10 days post-episiotomy, particularly within the cooling gel pad group. Wound healing rates were also reported to be higher within the cooling gel pad group. This trial also revealed that women were more satisfied when applying cooling gel pads. Although many reports have studied the efficacy of localised cooling treatment in relieving perineal pain of various origins, in Taiwan cold-gel packing for relieving perineal pain is not routinely applied. Among Taiwanese postpartum women and their families, ‘doing the month’ or ‘sitting the month’ are well accepted and respected traditional practices/customs followed by almost all Chinese worldwide. Women who are ‘doing the month’ are advised to avoid eating or having contact with any cold food or cold materials, as these are considered potentially harmful to their recovery (Bao et al., 2010). Given the cultural practice of remaining warm for one month following birth, this study is therefore important for this Chinese cultural group in Taiwan. To date, no previous study has investigated the effects of cold-gel packing on post-episiotomy pain in Taiwan, even though pain relief is considered the first priority in postpartum care. The study objective was to evaluate the effectiveness of localised cold-gel packing as a pain relief resource employed in postpartum women who had experienced vaginal birth with an episiotomy. This study could provide a clinical practice based on scientific evidence. Methods We used a quasi-randomised control trial; participants chose to have either the experimental or control group. Participants and setting This clinical study was conducted in the maternity ward of a Taipei City teaching ward that averages 50–80 births monthly. The study period extended from January to May 2010. During the data collection period, the average monthly births were 67 and rate of caesarean section was 44%. Most vaginal deliveries (more than 90%) received episiotomy at this hospital. The inclusion criteria included: women aged ≥18 years, delivering their child between 37 and 42 gestational weeks, with their newborn weighing between 2500 and 4000 grams at delivery. The exclusion criteria included: women who had medical or psychological disorders, delivered twins or a higher order gestation, and had any postpartum complications during the postparturition period. Sample size calculations were based on the Navvabi et al.’s study (2009), which used a Numerical Rating Scale (0–10) of the intensity of perineal pain (0 = no pain to 10 = worst possible pain). Our primary outcome was women’s pain intensity (0–10), measured as part of the Brief Pain Inventory, described below, 48 hours after giving birth. In order to detect a clinically significant reduction in pain scores from 4.36 (mean score at Day 2 postpartum in the control group) to 2.97 (in the cold-gel pad group), it was necessary to recruit 68 women into two groups (5% level of significance with 80% power). In anticipating a possible attrition rate of 10%, a target sample size of 37 participants per group was set.
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Instruments A structured questionnaire collected participant demographic and obstetric information. The intensity of pain and women’s satisfaction levels with pain management were the main measured outcomes. The pain intensity was measured by the short-form Brief Pain Inventory-Chinese version (Ger, 2004) and women’s satisfaction levels with pain management were evaluated by the pain management questionnaires within four hours of episiotomy repair (baseline), and at 12, 24 and 48 hours thereafter. The short-form Brief Pain Inventory consists of two subscales (pain intensity for two-item and pain interference on daily activities for seven-item). Ger (2004) reported a Cronbach’s alpha for the Brief Pain Inventory as .81 on the pain intensity subscale and .89 on the pain interference subscale. This questionnaire has been evaluated using a numeric rating scale (0–10). Higher scores indicated more intense pain and a more serious degree of pain interference on daily activities (including mood, sitting, lying down, walking, sleeping, urination, defecation). Our study’s Cronbach’s α coefficient for each subscale dimension ranged between .80 and .90 (n = 70). The questionnaire for women’s satisfaction level with pain management was developed by the researcher, and included a four-item questionnaire (such as satisfaction with pain management provisions from health-care providers, satisfaction with pain management resources). Scoring followed a six-point Likert-scale format, with 6 indicating very unsatisfied and 1 indicating very satisfied. Allocation to intervention or control group Potential participants, and those who met the study criteria, were approached individually. The study purpose and procedures were explained in detail by the researcher prior to providing written consent. Participants were informed of their right to withdraw from the study at any time. Seventy-three primiparous and multiparous women who had vaginal delivery with episiotomy and consented to participate were recruited and chose either the control or experimental group they wanted to be in. All participants received routine postpartum nursing care (including administered oral NSAIDs and warm sitz baths 24 hours after delivery).
Control group Control group participants provided demographic data after receiving routine postpartum care, responded to the BPI and satisfaction questionnaire at 4, 12, 24 and 48 hours after delivery.
Intervention group Cold-gel packing was the therapeutic intervention. Cold-gel pads were made of propylene glycol (antifreeze) and a cellulose compound (similar to that used in standard sanitary napkins). The cold-gel pad’s dimensions were 28 × 10 centimetres and weighed 242 grams. All experimental participants received an explanation about the intervention and its requirements, including (1) maintaining a cold-gel pad temperature between 12 and 150C, (2) replacing the cold-gel pad after 10 minutes of use in order to maintain the appropriate cooling temperature, (3) conducting one session to last 15–20 minutes. After receiving routine postpartum care and providing their demographic information, the experimental group participants took their first 15–20-minute cold-gel packing session. The researcher helped administer the first 15–20-minute intervention, and demonstrated how to apply cold-gel pads on the perineum. After that, participants were encouraged to use cold-gel packing frequently during the first four hours post-delivery. During the next three days, participants used it three times per day and as desired.
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The experimental group participants responded to the BPI and satisfaction questionnaire during the same time frame as the control group participants.
Data management
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The SPSS (18.0) statistical package was used for data analyses. Descriptive data analysis identified the demographic and obstetrics characteristics of the participants. Chi-squared, independent t-tests, or ANOVA, evaluated differences in demographic and obstetric variables between groups. The generalised estimating equations (GEE) model controlled the effects of study covariates and analysed the independent effects of cold-gel packing. The GEE approach considered withinperson variability and accounted for correlated data resulting from repeated measurements across different time points and multiple observations of the same individual (Zeger & Liang, 1986). A p-value < .05 (two-tailed) was considered statistically significant.
Ethics Hospital Institutional Review Board and nursing and maternity departments granted approval for this study (Taipei Medical University Hospital, IRB-2010-07-990707).
Findings A total of 73 women met the inclusion criteria and were enrolled in the study. Three participants withdrew their consent because of too many visitors, breastfeeding and rooming-in interference, and postpartum fatigue. As a result, the study included 35 participants in the experimental group and 35 in the control group. Table 1 provides a description of the 70 participants relative to demographic and obstetrical characteristics. Most subjects were nulliparas (87.1%), between 22 and 45 years of age (M = 32.1, SD = 4.3 years). The groups displayed no statistical differences in terms of demographic or obstetric variables (p > .05). We found that cold-gel packing decreased pain intensity, pain interference on daily activities and improved satisfaction with pain management. The mean pain intensity scores of the experimental group was 2.97 (SD = 2.73) and 5.57 (SD = 3.88) of the control group at 48 hours post-delivery (t = 3.24, p < .01; Table 2). The results of GEE show that changes to mean pain intensity scores indicated no significant differences between the experimental and control groups (p > .05). However, time-dependent changes indicated that post-test pain intensity scores decreased an average of 1.69∼6.81 points compared with pre-test results, implying a declining trend (Table 3). The interaction effect (group difference and time) revealed that the experimental group achieved a significantly greater drop in pain intensity values compared to their control group peers in the 48 hours post-delivery (β = −3.69, p < .01). In terms of mean pain interference on daily activities scores, at 48 hours post-delivery, the mean pain interference on daily activities scores for the experimental group (M = 41.23; SD = 14.11) were significantly lower than the control group (M = 33.51; SD = 12.21; t = 3.32, p < .001; Table 2). The results of GEE show that the changes to mean pain interference on daily activities scores indicated no significant differences between the experimental and control groups (p > .05). Time-dependent changes indicate that post-test pain interference on daily activities scores decreased an average of 8.43∼26.33 points over pre-test results, implying a declining trend (Table 3). The interaction effect (group difference and time) revealed that the experimental
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Table 1.
Demographics and obs-gyn information between two groups.
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Variables Age (M ± SD) Religious Yes No Occupation Yes No Education Senior high school and below College University and above Parity Nulliparous Multiparous Total weight gain (Kg, M, SD) The first stage of labour time (hour) M ± SD The second stage of labour time (hour) (M ± SD) Epidural anaesthesia Yes No Perineal trauma 1° laceration 2° laceration 3° laceration Using labour instruments Yes No Newborn weight(g, M, SD) New born Apgar Score 1 min (M ± SD) 5 mins (M ± SD)
Overall n = 70 N%
Experimental group n = 35 N%
Control group n = 35 N%
32.07 ± 4.30
31.34 ± 4.19
32.80 ± 4.34
17 (24.3) 53 (75.7)
8 (22.9) 27 (77.1)
9 (25.7) 26 (74.3)
17 (24.3) 53 (75.7)
11 (31.4) 24 (68.6)
6 (17.1) 29 (82.9)
14 (20.0) 19 (27.1) 37 (52.9)
7 (20.0) 7 (20.0) 20 (60.0)
7 (20.0) 12 (34.3) 16 (45.7)
61 (87.1) 9 (12.9) 14.69 ± 4.51 4.40 ± 4.33
31 (88.6) 4 (11.4) 14.90 ± 3.51 4.49 ± 3.90
30 (84.7) 5 (14.3) 14.47 ± 5.38 4.30 ± 4.77
.69a .85a
0.92 ± 1.27
0.89 ± 1.26
0.94 ± 1.29
.87a
59 (84.3) 11 (15.7)
29 (82.9) 6 (17.1)
30 (85.7) 5 (14.3)
1 (1.4) 67 (95.7) 2 (2.8)
0 (0.0) 33 (94.3) 2 (5.7)
1 (2.9) 34 (97.1) 0 (0.0)
64 (91.4) 6 (8.6) 3082.94 ± 346.08
32 (45.7) 3 (4.3) 3080.17 ± 358.42
32 (45.7) 3 (4.3) 3085.71 ± 338.50
.95a
8.96 ± 0.43 9.93 ± 0.26
9.00 ± 0.54 9.91 ± 0.28
8.91 ± 0.28 9.94 ± 0.24
.41a .65a
p .06a .78b .27b .34b
.72c
.74b .22b
1.00c
Notes: a Independent samples t test; b Chi-Square; c Fisher exact test (When the expectations of cases less than 5).
group achieved a significantly greater drop in interference on daily activities values compared to their control group peers at 12, 24 and 48 hours post-delivery (β = −5.54∼14.49, p < .05). Participants in the experimental group reported higher levels of satisfaction with pain management than the control group at 24 hours and 48 hours post-delivery (p < .05; Table 2). The results of GEE show that the mean satisfaction with pain management scores indicate no significant differences between experimental and control groups (p > .05). Time-dependent changes indicated that post-test satisfaction with pain management scores decreased an average of 0.91∼1.46 points over pre-test results, implying a declining trend (Table 3). The interaction effect (group difference and time) revealed that the experimental group achieved a significantly greater drop in satisfaction with pain management scores compared to their control group peers at 12, 24 and 48 hours after delivery (β = −0.97∼ −1.20, p < .05).
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Table 2. Differences in pain intensity, pain interference on daily activities and satisfaction with pain management between the two groups (N = 70).
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Outcome variables Pain intensity pp 4 hours(before intervention) pp 12 hours pp 24 hours pp 48 hours Pain interference on daily activities pp 4 hours(before intervention) pp 12 hours pp 24 hours pp 48 hours Satisfaction with pain management pp 4 hours (before intervention) pp 12 hours pp 24 hours pp 48 hours
Experimental group M±SD
Control group M±SD
t
p
11.62 ± 4.06 10.00 ± 3.22 6.09 ± 3.12 2.97 ± 2.73
10.54 ± 3.62 8.80 ± 3.43 6.46 ± 0.356 5.57 ± 3.88
−1.18 −.1.51 0.48 3.24
.242 .136 .633 .002**
41.23 ± 14.11 30.03 ± 11.02 17.97 ± 10.53 7.66 ± 7.59
33.51 ± 12.21 27.86 ± 11.78 20.94 ± 10.88 14.43 ± 9.37
−2.45 −0.80 1.16 3.32
.017* .429 .250 .001***
7.60 ± 1.82 6.20 ± 1.53 6.06 ± 1.39 5.54 ± 1.09
7.31 ± 1.88 6.89 ± 1.41 6.74 ± 1.36 6.46 ± 1.40
−0.65 1.95 2.09 3.04
.520 .055 .041* .003**
Notes: PP = post-partum; *p < .05; **p < .01; ***p < .01
Discussion Perineal pain is often experienced by postpartum women with episiotomy. It may arise during the first hours after birth and persist for months (Declercq et al., 2008). A systematic review has demonstrated that localised cooling treatments were effective at reducing perineal pain, swelling and bruising without adversely affecting wound healing (Steen, Briggs, & King, 2006). Our research findings suggest that cold-gel packing is an effective strategy for relieving perineal pain at 48 hours post-delivery, consistent with the findings reported by Jahdi et al. (2010), whose research on cold-gel pad efficacy in reducing perineal pain found that used cold-gel packing during the postpartum period decreased pain intensity at four hours, 12 hours and five days post-episiotomy. Other authors discovered similar results, demonstrating the efficacy of its employment on perineal pain post-episiotomy (Navvabi et al., 2009, 2011). In addition, past studies have shown that perineal pain often interferes with maternal sleep, emotions, ambulation, defecation and urination, resulting in a poor quality of maternal sleep, emotional instability and prolonged postpartum recovery time. This study also demonstrated that cold-gel packing can effectively reduce perineal pain interference on daily activities at 12, 24 and 48 hours post-delivery. This finding confirms that of Navvabi et al. (2011), whose study found that ice treatments had an effect on the interference of perineum pain with mood, sitting, babysitting, social activities and urinating, on the tenth day post-delivery. This study also found that cold-gel packing could increase the satisfaction level with pain management reported by women who had undergone episiotomy. Our findings are similar to those reported by Navvabi et al. (2009). In this study, the majority of participants in the experimental group reported coldgel packing was effective at reducing perineal pain, swelling and discomfort. Cold-gel pads are very comfortable because of their soft texture and suitable temperature. Therefore, participants expressed high satisfaction with cold-gel packing and a willingness to cooperate. Limitations It was not possible to randomise women into experimental or control group because under Chinese cultural norms, women have the right to decide whether to apply cold temperatures
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Table 3. Generalised estimating equations model on the effect of outcome variables for cold-gel packing (N = 70).
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Item Pain intensity Group (Experimental vs. control) Time Baseline (4 hours) 12 hours 24 hours 48 hours Group × Time Group × Baseline Group × 12 hours Group × 24 hours Group × 48 hours Pain interference on daily activities Group (Experimental vs. control) Time Baseline (4 hours) 12 hours 24 hours 48 hours Group × Time Group × Baseline Group × 12 hours Group × 24 hours Group × 48 hours Satisfaction with pain management Group (Experimental vs. control) Time Baseline (4 hours) 12 hours 24 hours 48 hours Group × Time Group × Baseline Group × 12 hours Group × 24 hours Group × 48 hours
β
SE
−0.37
0.58
reference −1.69 −4.81 −6.81 reference
0.50 0.50 0.50
.001**
